Skill diminta
Analytical ThinkingCommunication
Deskripsi
- Job Title: QA Operation Supervisor
- Job Summary
The QA Operation Supervisor is responsible for overseeing batch release activities, evaluating product quality compliance, and ensuring full alignment with regulatory standards. This role leads batch documentation reviews, oversees In-Process Controls, investigates deviations and non-conformances, and manages the end-to-end customer complaint resolution process.
- Key Responsibilities
- Batch Release & Compliance: Review batch records, SOPs, and validation documentation (deviation reports, CAPA, change controls) to ensure full regulatory compliance before authorizing product release.
- In-Process Control (IPC) Oversight: Supervise daily IPC activities to ensure strict adherence to Good Documentation Practice (GDP) standards and offer technical guidance.
- Deviation & CAPA Resolution: Lead root cause investigations for non-conformances, implement effective corrective actions, and track their long-term effectiveness alongside cross-functional teams.
- Customer Complaints & Document Lifecycle: Handle customer complaint investigations, sample retrievals, and tracking reports while maintaining proper formatting and issuance of controlled document formats.
Requirements
- Pharmacist with minimum 3 years supervisory experience in pharmaceutical or healthcare Quality Assurance.
- Deep working knowledge of Good Manufacturing Practice (GMP), Good Documentation Practice (GDP), CAPA processes, root cause analysis methodologies, and regulatory compliance requirements.
- Strong analytical thinking, investigation, and problem-solving skills.
- Excellent interpersonal and communication skills to effectively interface with cross-functional teams, stakeholders, and customers.